EDF has learned from multiple sources that political appointees at the Environmental Protection Agency (EPA) are on the verge of taking yet another huge lurch away from what the 2016 reforms to the Toxic Substances Control Act (TSCA) require when EPA reviews the safety of new chemicals prior to their market entry. A reporter at Bloomberg Environment has heard the same thing, and published an article this morning on some of the changes.

The Trump EPA apparently intends to abandon its November 2017 “New Chemicals Decision-Making Framework,” which already strayed far from the law’s requirements. That approach would have allowed EPA staff to limit their review of a new chemical only to the intended uses identified by its manufacturer, despite the law’s clear mandate that EPA consider known or reasonably foreseen, as well as intended, uses when conducting its review. Under the framework, where EPA had concerns about reasonably foreseen but not intended uses – rather than issue an order as required by the law – EPA would take two other steps: make a “not likely to present an unreasonable risk” determination for the chemical, clearing it to enter commerce; and issue a Significant New Use Rule (SNUR), which could trigger a separate, future review on any subsequently intended use, wholly divorced from the initial review.

Initially, EPA staff indicated the “not likely” finding would be made only once a final SNUR had been promulgated. That then slipped to have issuance of the finding coincide with the proposal of the SNUR. That then slipped further to allow the finding to be issued based on EPA’s mere intent to develop a SNUR.

Now, however, the Trump EPA plans to decouple completely its ability to issue a “not likely” finding from any dependency at all on promulgation of a SNUR. How then, you might well ask, would EPA consider reasonably foreseen uses of a new chemical? The short answer is, it won’t.

The longer answer is that EPA apparently intends to so narrowly define “reasonably foreseen” as to render it effectively the same as “intended,” ignoring the obvious fact that Congress clearly distinguished between the two. EPA may also loosen the threshold for making a “not likely” finding to such a degree that EPA would have to prove a risk is highly probable before it could place any conditions on a new chemical. This, too, flies in the face of the law, which requires EPA to impose restrictions whenever it finds a new chemical may present an unreasonable risk. Only in Trumplandia does “may present” mean “highly probable.”

Finally, the Trump EPA appears intent on never imposing testing requirements on new chemicals. This despite the fact that the 2016 TSCA reforms require that if EPA lacks sufficient information to review a new chemical, EPA must issue an order that either requires submission of the missing information or imposes conditions sufficient to address any potential risk in the absence of the information. This provision was motivated by the fact that the great majority of new chemical submissions lack any health or environmental data, and prior to the 2016 reforms, EPA had little choice but to allow such a chemical into commerce.

Avoidance of testing requirements is being achieved in two ways by the Trump EPA. First, by making the issuance of an order a rarity, EPA is taking away its primary means of imposing testing requirements. Second, EPA now intends even when an order is issued, to merely request that companies submit relevant information, rather than specifying the needed data and the methods to develop it (a longstanding feature of new chemical orders that is also called for under the testing provisions of TSCA).

To sum up the new approach:

Few, if any, orders

Few, if any, SNURs

Few, if any, testing requirements to fill information gaps

Effectively no consideration of reasonably foreseen uses

Many, many rubber stamps of new chemicals

Will they even bother to write it down?

A last, highly disturbing feature of EPA’s new approach is that political appointees are apparently resisting actually putting the new approach in writing. This suggests they are aware of how far the approach is straying from the law. But it also leaves professional staff in the lurch and begs the question of how the new rules are to be applied in a consistent manner.

Immediately after passage of the 2016 reforms and before new operating policies and procedures had been put in place, a common complaint of the industry was that different program staff were making different decisions in similar cases. Now, without detailed procedures in writing and without even the law to fall back on, this same thing could happen on steroids. Or are the political appointees simply assuming they’ll have lowered the bar so much that virtually every new chemical will go unregulated regardless of the potential risks it may pose?

In contrast to the last round of changes, where EPA issued documents describing the changes, held a public meeting, and subjected its approach to public comment, in this case we understand EPA plans to implement its approach without any public notice and without providing any written description of the changes, let alone the statutory basis for them.

Industry beware

I expect the motivation behind the new approach – crafted largely by political appointees who came to the agency directly from the American Petroleum Institute and the American Chemistry Council – is to address industry demands for quick and easy reviews of new chemicals “as in the good old days” before TSCA was reformed.

However, as I was quoted in the Bloomberg story saying: “Companies may want to think twice before supporting this illegal approach, which will call into question the actual safety of their new chemicals and put their investments at risk.”